Our
Quality
Management
System
is not used!
Paper summary
•
•
•
It is very difficult to have an efficient and effective Quality Management System (QMS).
Creating and maintaining a QMS is for organisations normally not core business.
And what if you are a company that wants to start developing and manufacturing for instance
medical devices on top of the existing portfolio of non medical systems? How can the QMS
help you with serving both product lines?
This presentation gives an overview on how to design, deploy and maintain an efficient and
effective QMS:
1.
2.
3.
4.
5.
6.
•
•
Requirements for the QMS have to be gathered also taking into account the characteristics of the organisation (size,
skill level of people, product portfolio, markets, …)
Next a suitable QMS design is to be chosen including how tailor towards projects can be achieved
Implementation of the design has to be done resulting in the QMS items like procedures and work instructions.
Verification of the implementation by means of document review and validation by piloting in a representative project.
Production phase of the QMS introduces the most difficult part of the product creation: deployment. How are the
employees trained in such a way that everyone in the organisation is skilled enough to work according to the QMS.
While working with the QMS, the end users (employees) will submit change requests. How must an organisation act
upon these requests? Deploy, deploy, deploy
For all steps mentioned above, hints and tips are given coming from real life examples. Not
only what to do but also what NOT to do.
Examples shown will be based on the international standard ISO 9001. On top of that,
requirements according to the medical device standard ISO 13485 are implemented.
© Process Vision – Help! Our QMS is not used
Slide 2 of 60
The latest version of this presentation
• Is to be found on my website www.processvision.nl
© Process Vision – Help! Our QMS is not used
Slide 3 of 60
Willem van den Biggelaar
• Quality and Medical Regulatory Consultant
• Certified DEKRA auditor for ISO 9001 / ISO 13485
• Setup several ISO 9001 / 13485 certified Quality
Management Systems (QMS)
• Previous jobs
• Quality Assurance Officer (5 years)
• System Tester (1 year)
• Embedded software engineer (7 years)
© Process Vision – Help! Our QMS is not used
Slide 4 of 60
Content
• The 6 steps of developing and maintaining a QMS
1.
2.
3.
4.
5.
6.
Define Requirements
Design
Implement & Verify
Validate (piloting)
Deploy (initial)
Under change control
• Treat it like a project
• FAQ
© Process Vision – Help! Our QMS is not used
Slide 5 of 60
Like a V-cycle
Stakeholders
wishes
Project Plan
Change
Requests
Quality Manual
- Quality Policy
- Management Commitment
- Organisation
- Scope
Define
Requirements
Quality Manual
QMS Index
- Processes + owners + interfaces
- procedures per process
- process owner
Validate
(pilot run)
Procedure A
process A
--- Template A
--- Work instruction A
--- Guideline A
Procedure B
process B
-- Template B
-- Template C
Procedure C
process A
Procedure D
process C
-- Guideline B
Review
Reports
Verify
Design QMS
Procedure interfaces
- connecting flow charts input/outputs
- defining datastores
DPQ-0001a2
2009 Sept 15
Version 01
Status: Approved
Product Creation
Select, monitor
and evaluate a
supplier
How to accept
purchased
products
Purchased
Product
Acceptance
Supplier
Management
PP
Supplier needed
PP
Product
needs
Accepted
acceptance Product
Design,
implement, verify
and validate
Traceability Matrices
Product
Creation
Plan, Specs, Designs,
Reports, Manuals
PCP
Labeling/Translation
Requirements
DPQ-0028
Product
Security &
Privacy Reqs
DPQ-0035
PCP
Disclaimer
Be aware. Only the most obvious
interfaces are drawn. In real life
much more interfaces exist.
Commercial
docs
Design
History File
Device Master
Record
Software Tools
Validation &
Control
Start
Clinical Evaluation
for IVD MD
DPQ-0025
PCP
SW tool
validation reqs
for production (ORP)
Plan, TestSpec,
Report
DPQ-0004
PCP
Handle changes
on approved
items
Product
Change
Control
DPQ-0002
PCP
DPQ-0032
Q&R
Enable recall
investigations .
Enable tracking
towards hospitals
Safety/security
Modules
Templates Guidelines
Product
Traceability
DPQ-0013
Work
instructions
ORP
510k, PMA, CE
Performance
Evaluation
Start
Analyze & report
Safety & Security
aspects
Product Risk
Management
Risk
Management
File,
Risk CR/PRs
CR/PRs
SW tool
validation reqs
for development
t
en st
m ue
lop req
ve
De ange
Ch
Security &
Privacy Reqs
Safety/security tagged
requirements
Service
docs
Transfer
DHF / DMR
To ORP
PCP
DPQ-0005
PCP
Risk Analysis
Needed
DPQ-00019
New product
Product
Labeling
Annexes
Product
Requirements
Traceability
Traceability
needed
Products / Services
One of the
product
preservation
control measures
To where must
requirements be
traced
DPQ-0034
DPQ-0012
Product Creation Process
Purchasing Process
Regulatory
Approval
Market
Clearance
Order Realisation Process
DPQ-0031
Customer Service Process
Q&R
Quality & Regulatory
Procedures
- scope
- input / output / datastores
- activity descriptions
- responsible
roles
A
input
Implement
© Process Vision – Help! Our QMS is not used
Slide 6 of 60
Deployment /
Change Control
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Training Material
What is a Quality Management System?
• Describes a set of procedures an organization needs
to follow in order to meet its business objectives.
• Small organizations:
• mostly no official system
• just ‘our way of doing things’
• not written down, in the head of the staff.
• Organization gets larger
• Written instructions about how things are done needed
• Assure nothing is left out
• Assure everyone knows who needs to do what, when, how.
© Process Vision – Help! Our QMS is not used
Slide 7 of 60
Why do you need a QMS (stakeholder wish)
• Customer demand
• E.g. for medical devices, it is essential for a manufacturer
that its suppliers are ISO 13485 certified
• Organisation communication gets complexer
• More people in one discipline, larger projects
• Multidisciplinair, e.g.
• Designers <-> Testers
• Designers <-> Engineers <-> Production
• Sales <-> Production <-> Logistics
• Improve process / product quality
• Standard way of working in order to focus on product
© Process Vision – Help! Our QMS is not used
Slide 8 of 60
1. Define requirements for a QMS
Requirements for the QMS have to be gathered also taking into
account the characteristics of the organisation (size, skill level
of people, product portfolio, markets, …)
© Process Vision – Help! Our QMS is not used
Slide 9 of 60
1. Define: Product Market Combination (PMC)
• Product examples
• Healthcare
• Automotive
• Machinery
• Consumer
• Aerospace
• Food
• Pharmacy
• Measurement instruments
• Railway
• Radio and telecom
• Market examples
• Europe
• USA
• Canada
• China
• Australia
• Russia
• Asian pacific
• Africa
• South America
Each combination has its own legislation to which you must comply
© Process Vision – Help! Our QMS is not used
Slide 10 of 60
1. Define: Comply with International standards
• Examples of QMS standards
 ISO 9001 – General standard
 ISO 13485 – Medical
 AS 9100 – Aerospace
 TS 16949 – Automotive
 TL 9000 – ICT
 ISO 27001 – IT Security
 ISO 14001 – Environmental
 OHSAS 18001 – Occupational health and safety
• Which to choose depends on Product Market
Combination
© Process Vision – Help! Our QMS is not used
Slide 11 of 60
1. Define Company Quality Policy
© Process Vision – Help! Our QMS is not used
Slide 12 of 60
1. Management must show commitment
• Let top management have quality on agenda of
(yearly) personnel meeting
• (Changes to) Quality policy
• Metric
• Let department managers have quality on (monthly)
department meeting agenda
• (Changes to) Quality policy
• Results internal and external audits
• Management must reserve resources for quality
• QMS maintenance
• Quality Audits
© Process Vision – Help! Our QMS is not used
Slide 13 of 60
1. Define: Fit to your organisation
• Size of organisation
• Number and type of departments
• Skill and competence level of the employees
• Examples
Id
A
B
C
Product
Respiratory
medical
equipment
Printed Circuit Assembly
(PCA)
Different types of
mechatronics products
#Staff
10
50
Education
Academic,
Large experience
in product
Secondary school
80
Academic
Key departments
Marketing & sales
Development & Engineering
Outsourced Production
Purchase / Sales
Mass production
Development & Engineering
Prototype production
• A: high level procedures leaning on medical standards
• B: detailed work instructions for production
• C: high level procedures based on different standards
© Process Vision – Help! Our QMS is not used
Slide 14 of 60
1. What I have seen gone wrong
• No or little management commitment, e.g.
• “High quality products” is leading in the quality policy but
management decides to deliver less quality if that saves
money
• Not enough resources available
for QMS updates / internal audits
• People have no idea that what the company quality
policy is
• Too heavy QMS for an organisation
© Process Vision – Help! Our QMS is not used
Slide 15 of 60
2. QMS architecture & design
Next a suitable QMS design is to be chosen including how tailor
towards projects can be achieved
© Process Vision – Help! Our QMS is not used
Slide 16 of 60
2. Design: Well known QMS architecture
Quality
Manual
QMS scope and requirements
Quality Policy
Organisational structure
Processes including owners
Mandatory to follow
Procedures
Annexes:
Workinstructions Templates
Guidelines Checklists
Quality Records
© Process Vision – Help! Our QMS is not used
Slide 17 of 60
Annexes:
Extra help to be more
efficient and effective
All documents and records
that proof that the QMS is
executed conform its
requirements
2. Design: Traceability between layers
Process
To which process & owner does a procedure belong
Procedure
Which template has this procedure
Template
From which template is this record derived?
Quality Record
© Process Vision – Help! Our QMS is not used
Slide 18 of 60
2. Design: Traceability between layers
Ref 1: Example of a procedure that refers to its process (and owner)
Process
To which process & owner does a procedure belong
Procedure
Ref 2: Example of a procedure that refers to its templates,
guidelines,.....
Which template has this procedure
Template
From which template is this record derived?
Quality Record
Ref 3: By using the latest released template (id+version), reference 3 is assured
© Process Vision – Help! Our QMS is not used
Slide 19 of 60
2. Design: the processes
• Divide in main processes and supporting processes
• Assign process owners:
• Design/Own the process
• Deploy/Advocate the process
• Measure the process
• Maintain/Improve the process
• Do NOT make the QA manager owner of everything
• Processes ≠ Departments!
• A product creation process is a divided responsibility not only
owned by the development department
• Design the interfaces between the processes
© Process Vision – Help! Our QMS is not used
Slide 20 of 60
2. Design: process overview in one picture
Managing
Director
Business Strategy Process (BSP)
Scope
Business Strategy & Planning
Feed
back
Sales
Roadmapping
Business
Plan
MT
Product Creation Process (PCP)
New Product Introduction
Product Design
Require
ments
D&E Manager
DHF
Definition &
Quotation
Concept
Design
Proto
Pilot
Series
TPD + PR
TPD
Order + Forecast
Customer
Procurement &
PO control
Purchasing (PUR)
Commodity
Strategy
Purchasing Manager
Selection
Contrac
ting
Accept /
Process
Evaluation
MPS
DMR
MPS
Production
Planning & WO
control
Manufacturing Process (MAP)
Supplier
Shipping
Planning / Work Order (WO) Ready
Purchase Order (PO) / Forecast
Warehouse
(Receival)
Manufacturing
Manager
Warehouse
(Expedition)
Stock
Quality Assurance / Production Engineering (QA/PE)
Incoming Inspections CTQ/CTS, Non Conforming Goods, SPC, Calibration
QA & PE
Manager
FEBV
Support
HRM
QESH
ICT
© Process Vision – Help! Our
QMS is not
used IT Manager
Q/HSE
HR Manager
Manager
Slide 21 of 60
Delivery
Note
(Final)
Assembly
and testing
Handling and
Cleaning
Parts
Supply Chain
Manager
Logistics (LOG)
FInance
Facilities
Financial
Director
Financial
Director
Product
DHR
2. Design the procedure interfaces
• Allocate to each process the neccessary procedures
• Guard the interfaces between the processes
• Again, put it all in a picture
• Tip: you can use these pictures for training purposes
© Process Vision – Help! Our QMS is not used
Slide 22 of 60
2. Design: Procedure interface per process
© Process Vision – Help! Our QMS is not used
Slide 23 of 60
2: Design: Guard the interfaces
© Process Vision – Help! Our QMS is not used
Slide 24 of 60
2. What I have seen gone wrong
• No process owners, QA does all the work
• Interfaces between procedures not aligned
• No overview of processes or
procedures just a bunch of “howto’s”.
• No strict division between QMS
items (Q manual, procedures and
annexes) and Quality Records
© Process Vision – Help! Our QMS is not used
Slide 25 of 60
3. Implementation & Verification
Implementation of the design has to be done resulting in the QMS
items like procedures and work instructions.
Verification of the implementation by means of document review
© Process Vision – Help! Our QMS is not used
Slide 26 of 60
3. Write the procedures
• Don’t let key users be authors
• Most of the time they don’t have the time for it
• Most of the time they are not keen on doing it
• Most of the time they are not capable of doing it
• Let stakeholders review (walkthrough) them:
• Process owner (if not author)
• Process owners for which their process interface
• Key users – can I use it? Is it complete?
• Quality Manager – is it compliant with regulatory
© Process Vision – Help! Our QMS is not used
Slide 27 of 60
3. Tailoring (deviation of) the QMS
• Always allow projects to tailor towards own needs
• Let tailoring be documented in the project plan
• Let tailoring be approved by the QA manager
• Tailoring must be compliant with regulations
• If much tailoring occurs, its a signal that perhaps the
QMS is not suitable to the needs of the organisation
© Process Vision – Help! Our QMS is not used
Slide 28 of 60
3. Write the templates and forms
• Basis for the quality records so be precise
• First make mother template(s)/form(s)
• Layout
• Default content
• Next, make templates/forms for all possible
document types
• Input
• Mother template/form
• Best practices
• Procedures
• Again let stakeholders review (walkthrough) them
© Process Vision – Help! Our QMS is not used
Slide 29 of 60
3. Write the other annexes
• If needed, guidelines
• If needed, checklists
• If needed, work instructions
• In native language if users are native speakers only
• Again let stakeholders review (walkthrough) them
• Checklists can evolve during history of the
organisation, if same things go wrong over and over
again, put them in checklists
© Process Vision – Help! Our QMS is not used
Slide 30 of 60
3. Write training material
• While writing you already have to replace yourself in
the minds of the users of the QMS
• And maybe find out
• A procedure has become much too complex
• A template is not usable
• .........
© Process Vision – Help! Our QMS is not used
Slide 31 of 60
3. Deal with different regulations
• Suppose your organisation makes products for both
medical and non medical industry
• Either write different procedures for each industry
• Or address the difference within the procedures &
templates. E.g.
© Process Vision – Help! Our QMS is not used
Slide 32 of 60
3. What I have seen gone wrong
• Local department templates and work instructions
not under QMS control
• No mother templates so no escape if a template is not
available leading to non compliant project
documentation
• Procedures long (lot of text, no pictures) and tedious
© Process Vision – Help! Our QMS is not used
Slide 33 of 60
4. Validate the QMS
validation by piloting in a representative project.
© Process Vision – Help! Our QMS is not used
Slide 34 of 60
4. Validate the QMS: choose pilot projects
• Try to validate QMS on all its possible intended uses
• Choose (if possible)
• Different type of projects. E.g:
• 1 Medical project
• 1 Machinery project
• Different size of projects. E.g.:
• 1 very small projects (1 – 10 FTE)
• 1 very large project ( 50+ FTE)
• 1 medium project (10 – 50 FTE)
• Choose projects that are just started
• Each project leader will have a “reason” not to be chosen
• Projects with high time pressure are reluctant to be chosen
© Process Vision – Help! Our QMS is not used
Slide 35 of 60
4. Validate the QMS: process the results
• Let projects log all issues they come across
• Implement the issues in the QMS
• Review changes with stakeholders
© Process Vision – Help! Our QMS is not used
Slide 36 of 60
4. What I have seen gone wrong
• No piloting at all, simply “dump” the new process into
live projects
• Only piloting with a small (easy) non typical project
© Process Vision – Help! Our QMS is not used
Slide 37 of 60
5. Initial deployment
Production phase of the QMS introduces the most difficult part of
the product creation: deployment. How are the employees
trained in such a way that everyone in the organisation is
skilled enough to work according to the QMS.
© Process Vision – Help! Our QMS is not used
Slide 38 of 60
5. Deployment - training
• Create training plan: who must be trained in what and
when (input is QMS index)
• Initial training of people
• Re-train people pro-active (regular basis) or re-active
(if needed)
• Don’t forget training program for new employees
• Let QA officer / Process Owner check by
• Sanity checks (coffee corner, project meetings)
• Official audits
© Process Vision – Help! Our QMS is not used
Slide 39 of 60
5. Deployment – explain via wall posters
• Use posters on walls, coffee corners, team rooms,
etcetera
• Also put in FAQ’s, contact persons
• Explain them to the team
• If changes are due, hang new posters
• And re-explain
• The team can never say again “we didn’t know”
© Process Vision – Help! Our QMS is not used
Slide 40 of 60
An example
Master Integration Plan
Hardware release cycle not included
Red Sticker
Not standalone testable subsystem A & B
Both released by preSIT owner (IM)
SRT
PDC 30.xx
Subproj TM: timing + Q
Test team: execution
ART/SAT
SW TL: timing + Q
Dev team: execution
Subpro IM:
releases
SW TL: timing+Q
PUBLISHED
ACQ 1.3 Pub
DB
2.5 Pub
HOST 2.6 Pub
Infra 4.5 Rel
RELEASED
Subsys A+B
Subsystem A
SSAT
preSIT
Synch
Bom
Bom
Subsystem A
internally built &
tested
PUBLISHED
System projects
Warroom: accept /
reject deliveries
ACQ 1.7 Rel
DB
2.8 Rel
HOST 2.8 Rel
GEO 3.1 Rel
Infra 4.5 Rel
FATs
SYSTEM_
INTEGRATED
Subsystem B
SSAT
Bom
Bom
Subsystem B
internally built &
tested
ACQ 1.3 Pub
DB
2.6 Pub
HOST 2.6 Pub
Infra 4.4 Rel
RELEASED
Rocket B1 Test dependencies
SW TL: identifies & signals
conflicts & takes action
Subsystem
architect
PDC 30.xx
Existing
functionality
Rebuild +
Regression test
with merged BOM
Conflicting
BOMs
Synch
System IM: identifies
& signals conflicts
Subprojects: take
action
System
Regression
Test
New
functionality
Test
PUBLISHED
SSAT
PUBLISHED
Subsystem D
internally built
& tested
preSIT
Synch
Subsystem D
SSAT
ACQ 1.0 Rel
DB
1.9 Rel
HOST 2.4 Rel
GEO 3.5 Rel
Infra 4.5 Rel
SRT
SRS
ART/SAT
Supply chain
subsystem chain per subproject
FRS
PDC 30.yy
ACQ 1.0 Rel
DB
1.9 Rel
HOST 2.4 Rel
Infra 4.5 Rel
FAT
SDS
SIT
preSIT
Existing
functionality
MiscSys
Viewing
PandA
Geometry
Q: What if a subsystem must deliver at the same time different functionality to 2 or more customers?
A: That subsystem can only release if the last customer has released
Q: What if a delivery is not on the MIP but is already needed by a customer e.g. due to incompatible
interfaces?
A: Either change the MIP or deliver that subpart as published to the customer.
database
ID
system warroom - 4 subprojects
Production
requirements
RELEASED
Subsys C & D
GEO 3.1 Rel
Bom
New
function
ality
Subsystem C
Bom
Subsystem C
internally built
& tested
PRS (CIS only)
SSIS
FAQ
Host
Blueprint Development chain
Scenario 2
UI
FSSys
Acquisition
SIT
Standalone testable subsystem C & D
Independent released by both subproject IMs
SYSTEM_
INTEGRATED
Integration
dependencies
ACQ 1.0 Rel
DB
1.9 Rel
HOST 2.4 Rel
GEO 3.0 Rel
Infra 4.5 Rel
Bom
Other subsystem
needed for test new
MIP delivery
Acquisition
B Nijhuis
All except Panda,
MiscSys, UI modules
Database
K Oberzynski
None
FS Sys
J Smans
Geometry
FSFW
P Dingemans
None
Geometry
E Suijs
None
Host
F Jacobs
None
ID
P Meuleman
?
Infra
P Dingemans
Yes:
IP
E Oerlemans
Viewing
Mercury
P Meuleman
?
Misc System
A v Beurden
None
Panda
A Oberzynska
Yes:
UI
L Berek
Viewing, Panda, Geo,
Acq, UI modules,
Misc Sys
UI modules
M Boumans
None
Viewing
G Hamerslag
IP
VxWorks
I Canjels
?
Subsystems with FSC need FSFW
SYSTEM_
INTEGRATED
Bom
Subsystem
System projects
Warroom: accept /
reject deliveries
PDC 30.zz
GEO 3.1 Rel
Bom
SSAT
Bom
Subsystem C
fRole system SCM
all functionality mapped on subprojects
(Phobos, Acquisition, Eagle, Movement)
PDC 30.xx
Integrated environment
Action points:
Zonnetjesplaat
Bom
System IM:
responsible +
author
New
function
ality
SYSTEM_
RELEASED
PDC 30.xx
SW TL: timing+ Q
Test/Dev team:execution
UI modules
IP
System project
Sub(system) project
Green Sticker
SYSTEM_
TESTED
Below two possible scenarios (1 & 2) are given to deliver to the system PDC
Pizza items mapped to in-between deliveries based on

time
Deviations to these scenarios are only allowed if they still comply to the PUBLISHED and RELEASED definitions.

target system resources

technical dependencies between subsystems (architecture)
Scenario 1
Red Color
Blue Color
Bom
SDT: responsible
SWAT: author
Id: XDB040-043084
Author: W vd Biggelaar
Version : 12
Status: Proposal
Date: 6 Oct 2004
System Development Cycle
Bom
Allocation table
Pizza items mapped on subsystems
C/V PUBLISHED subsystem

guarantee and support depends on agreement between involved parties.

changes via CR/PR’s after agreement between involved parties on scope (which WIP parts)

previously PUBLISHED or higher functionality keeps working: regression tests succeeded

agreed new functionality (delivery of MIP) is (partly) implemented

dependent on change impact one or more non-official MTs and/or UATs succeeded

No part of PDC unless war room decides otherwise
C/V RELEASED subsystem

official supported release (fixes will be made when users can not wait until the next RELEASED baseline)

release note (at least: new functionality; known bugs; solved PRs on previous RELEASED; tests executed & passed)

changes via CR/PR’s on those parts that are released (MIP delivery)

previous PUBLISHED or higher functionality keeps working: regression tests succeeded

agreed new functionality (delivery of MIP) works correctly with its other MIT deliveries

official MTs, UATs, SSAT & preSIT succeeded for implemented part as indicated in release note

will be part of PDC after acceptance by preSIT owner (see MIP) & system war room
War room decides on all conflicting situations
Note: CIS delivers PUBLISHED subsystems to C/V. They RELEASE their subsystems at C/V’s SYSTEM_RELEASED
SSAT
Architecture
units per subsystem
URS / UDS
UAT
MRS / MDS
MT
Code
infra
© Process Vision – Help! Our QMS is not used
Slide 41 of 60
5. Deployment – How to find the QMS
• Make several search possibilities
• On terms, e.g. via google like search
• On lists, e.g via the QMS index list
• On pictures – e.g. via a clickable process
• Via different views
© Process Vision – Help! Our QMS is not used
Slide 42 of 60
5. Find the QMS – via clickable process
ALL PROCESSES
Managing
Director
Business Strategy Process (BSP)
Scope
Business Strategy & Planning
Feed
back
Sales
Roadmapping
Business
Plan
MT
Product Creation Process (PCP)
New Product Introduction
Product Design
Require
ments
D&E Manager
DHF
Definition &
Quotation
Concept
Design
Proto
Pilot
Series
TPD + PR
TPD
Order + Forecast
Procurement &
PO control
Purchasing (PUR)
Commodity
Strategy
Purchasing Manager
Selection
Contrac
ting
Accept /
Process
Evaluation
MPS
DMR
MPS
Production
Planning & WO
control
Manufacturing Process (MAP)
Warehouse
(Receival)
Delivery
Note
Manufacturing
Manager
(Final)
Assembly
and testing
Handling and
Cleaning
Parts
ONE PROCES
Shipping
Planning / Work Order (WO) Ready
Purchase Order (PO) / Forecast
Supplier
Supply Chain
Manager
Logistics (LOG)
Customer
Warehouse
(Expedition)
Stock
Quality Assurance / Production Engineering (QA/PE)
Incoming Inspections CTQ/CTS, Non Conforming Goods, SPC, Calibration
QA & PE
Manager
Product
DHR
FEBV
Support
HRM
QESH
ICT
FInance
Facilities
HR Manager
Q/HSE
Manager
IT Manager
Financial
Director
Financial
Director
ONE PROCEDURE
ONE TEMPLATE
© Process Vision – Help! Our QMS is not used
Slide 43 of 60
5. Find the QMS – template one click away
© Process Vision – Help! Our QMS is not used
Slide 44 of 60
5. Find the QMS – clickable with different views
© Process Vision – Help! Our QMS is not used
Slide 45 of 60
5. What I have seen gone wrong
• No deployment at all, just issue changes, nobody
knows or notices it
• Deployment by saying ”Everybody can read the
procedure“
• Deployment by going through the procedure step by
step in a detailled manner
• People have no clue where to find the QMS
• And if they have found it, you cannot find what you
search for
© Process Vision – Help! Our QMS is not used
Slide 46 of 60
6. Change Control
While working with the QMS, the end users (employees) will submit
change requests. How must an organisation act upon these
requests? Deploy, deploy, deploy
© Process Vision – Help! Our QMS is not used
Slide 47 of 60
6. Change Management
• Setup a change request tool
• Let users submit change requests in a easy way
• Form a Change Control Board
• Process the change requests on weekly basis
• If backlog occurs, you will loose user commitment
• Change QMS according to previous mentioned steps
• Release on regular basis, e.g. Quarterly and keep
deploying
• In the end, users must “own” the QMS not QA
manager or process owner
© Process Vision – Help! Our QMS is not used
Slide 48 of 60
6. What I have seen gone wrong
• No change control / configuration management /
version control leading to
• draft procedures being published
• Templates being deleted by personell
• Large backlog on change requests leading to
unmotivated personell to issue new requests
© Process Vision – Help! Our QMS is not used
Slide 49 of 60
Putting it all together
Start a project if you want to create/maintain the QMS
© Process Vision – Help! Our QMS is not used
Slide 50 of 60
Putting it all together – start a project!
• Updating or making a QMS is a normal project
• Appoint a project leader
• Create a project plan and track progress
• Have regular meetings with stakeholders
© Process Vision – Help! Our QMS is not used
Slide 51 of 60
Example of QMS development plan
ISO 13485 project Way of Working and Global Plan
Tracking
QMS
publication
board
For pilot
project(s)
Procedures Progress
50
45
40
Axis Title
35
30
walkthroughed
25
proposal
20
QMS
publication
board
For pilot
project(s)
not existing
15
10
5
0
Stage 1
Training Done
Management Review done
Process audits done
Start
Project
01-2010
04-2010
Week 18
Define
- Q Manual
- Q Index
- Pilot project(s)
te
P
r w ub
al lish
kt
hr
ou
gh
Electronic Reviews (no
meetings): should only
reveal minor issues.
Af
Walkthroughs of flow
charts and proc
interfaces at weekly
progress meeting
leading to informal
updates (invite key
users)
Official e-reviews Q Manual
& procedures
08-2010
Week 35
Walkthroughs
Process Owners:
Write (buddy with WBig)
Q Manual / Index - Parts of Procedure Interfaces
walkthroughed
- Flow charts
Pilot projects
WBig
defined
- Total procedure interfaces
- Design webinterface
All red and orange
procedures synchronised
with each other
(proposal)
- Write annexes, check
with 1 peer and publish
- Xtra text flowcharts
(front, back)
- connecting flow charts input/outputs
- defining datastores
Select, monitor
and evaluate a
supplier
PP
Supplier needed
Product
Requirements
Traceability
Traceability
needed
Traceability Matrices
Product
Creation
DPQ-0035
PCP
Safety/security tagged
requirements
Commercial
docs
Design
History File
Product Risk
Management
Risk
Management
File,
Risk CR/PRs
DPQ-0004
PCP
Service
docs
Device Master
Record
Software Tools
Validation &
Control
Plan, TestSpec,
Report
Start
Clinical Evaluation
for IVD MD
DPQ-0025
PCP
SW tool
validation reqs
for production (ORP)
Handle changes
on approved
items
CR/PRs
SW tool
validation reqs
for development
Analyze & report
Safety & Security
aspects
Product
Change
Control
DPQ-0002
PCP
Product
Traceability
DPQ-0013
DPQ-0032
Q&R
input
1 A4
Hints:
- merge sequential
activities same owner
- activities in imperative
sense
Priorties:
Red = High (ISO, needed for project))
Orange = Medium (ISO)
Green = Low (non ISO, CCM wish)
© Process Vision – Help! Our QMS is not used
Slide 52 of 60
ORP
510k, PMA, CE
Performance
Evaluation
Start
Enable recall
investigations .
Enable tracking
towards hospitals
Safety/security
Modules
nt st
me ue
lop req
ve
De ange
Ch
Product
Security &
Privacy Reqs
Disclaimer
Be aware. Only the most obvious
interfaces are drawn. In real life
much more interfaces exist.
Quality Manual Index File
- procedures per process
- process owner
Plan, Specs, Designs,
Reports, Manuals
PCP
Labeling/Translation
Requirements
Transfer
DHF / DMR
To ORP
Security &
Privacy Reqs
DPQ-0005
PCP
Risk Analysis
Needed
DPQ-00019
New product
DPQ-0028
PCP
Procedure A
process A
--- Template A
--- Work instruction A
--- Guideline A
Procedure B
process B
-- Template B
-- Template C
Procedure C
process A
Procedure D
process C
-- Guideline B
PP
Product
needs
Accepted
acceptance Product
Products / Services
Design,
implement, verify
and validate
Product
Labeling
Work
instructions
To where must
requirements be
traced
DPQ-0034
DPQ-0012
Abbreviation
&
Definitions
file
How to accept
purchased
products
Purchased
Product
Acceptance
Supplier
Management
Guidelines
DPQ-0001a2
2009 Sept 15
Version 01
Status: Approved
Product Creation
One of the
product
preservation
control measures
Write / Executing
Training.
At least:
Quality Policy
End Q4
2010
- default English
- in Dutch if users are Dutch speakers only
Procedure interfaces
Update of
A&D file by
all owners
QMS approved
Annexes
Templates
Quality Manual
- Quality Policy
- Organisation
- Scope
- Processes
- Process descriptions
- Process Onwers
A
P
Or fter ubl
an E-r ish
ne ev
x w iew
rit s
te
n
17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35
Product Creation Process
Purchasing Process
Regulatory
Approval
Market
Clearance
Order Realisation Process
DPQ-0031
Customer Service Process
Q&R
Quality & Regulatory
A ;dsa
;lkf
asp’;sd
fdsafda
s fdas
Flow charts (incl. blue italic)
- scope
- input / output / datastores
- activity descriptions
- responsible roles
output
A ;dsa
;lkf
asp’;sd
fdsafda
s fdas
A ;dsa
;lkf
asp’;sd
fdsafda
s fdas
A ;dsa
;lkf
asp’;sd
fdsafda
s fdas
Stage 2
Certification
Gather
evidence
In pilot
Project(s)
End Q1
2011
Summary
• Did this help to answer the question “What to do if
our QMS is not used?”
• In short
• Treat the QMS as a normal product to be developed,
implemented, verified and validated, released, put under
change control / version control / configuration
management
• Treat the way you develop the QMS as a normal project
• Deploy, deploy, deploy
• The users must feel they “own” the QMS
© Process Vision – Help! Our QMS is not used
Slide 53 of 60
© Process Vision – Help! Our QMS is not used
Slide 54 of 60
• InfoQ did and interview with Willem about the benefits of
having a QMS, dealing with multiple regulations, assuring
adherence to a QMS, how a QMS can support agility and
deploying a QMS in an agile way
• A summary is to be found in the upcoming sheets.
• The complete interview can be found on
http://www.infoq.com/news/2014/10/getting-QMS-used
© Process Vision – Help! Our QMS is not used
Slide 55 of 60
• In your view what is a QMS? What are the benefits of having
one?
• A QMS is the documented set of agreements about the way of working
within a company
• Without this agreement each design project and/or production team
works according its own insights which can lead to a wide variation in
the quality of products and inefficient work
• Can you name some of things that often go wrong when
organizations are deploying a QMS?
• Problems that I often see in organizations with Quality Management
Systems are:
• The idea that writing it down is enough
• Only performing initial deployment
• All deployment by the quality person feeding the idea that the QMS is his/hers
responsibility
© Process Vision – Help! Our QMS is not used
Slide 56 of 60
• From a governance point of view a QMS must assure that
applicable regulations are being met. Do you have good
practices when dealing with multiple overlapping or conflicting
regulations or regulations from different standardization
bodies?
• You can make a cross matrix to check if all regulations are “in”
• I always try not to split up (make separate) procedures but sometimes it
can be more convenient: an example is a work instruction to bring a
medical device to the market and a work instruction to bring a
machinery to the market.
• I have not seen any conflicting regulations yet as in principal they all
want the same: are you in control
© Process Vision – Help! Our QMS is not used
Slide 57 of 60
• What can you do to assure that a QMS is followed and adhered
to in an organization?
• First you need to do proper deployment
• Next, check if QMS is followed by official audits and non official
“audits” (like listening to people talking in the coffee corner)
• You need to re-deploy if issues are found
• How can you validate a QMS to see if it supports an
organization in reaching it's goals?
• You can’t by validating as I described it (piloting) but you can by
measuring on the processes. E.g. By means of GQM (Goal Question
Metric) method
© Process Vision – Help! Our QMS is not used
Slide 58 of 60
• If an organization is adopting agile or lean processes would
they still need a QMS?
• Yes! You always have output so you need templates. You always want a
common way of working so you need procedures or work instructions
• What kind of changes are needed to a QMS to support agility?
• Agility is just a way of working, so write down how you do it and put it
in your QMS. I have seen organizations who keep agile development
outside their QMS. It became a work instruction in each of their
projects. That is not needed and can be ineffective.
• Could you develop and implement a QMS using an agile
approach, e.g. in iterations in stead of a big bang deployment?
• Of course, certainly if you don’t know the exact requirements at the
start. You could also develop it while the first project is already running,
e.g. the first increment should deliver the requirements and the project
management processes
© Process Vision – Help! Our QMS is not used
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© Process Vision – Help! Our QMS is not used
Slide 60 of 60